The past week was busy for the biotech sector with earnings updates by most biotech bigwigs along with regulatory and other pipeline updates as well as collaborations. Most companies have delivered better-than-estimated top and the bottom-line numbers. Label expansion of existing drugs and other pipeline updates grabbed headlines.
Recap of the Week’s Top Stories:
Alexion, Celgene, Biogen Fire on All Cylinders: The going has been good so far for the biotech sector in first-quarter earnings season. Most bigwigs surpassed on both earnings and sales. For instance, Biogen (BIIB - Free Report) emerged with flying colors, fueled mainly by a strong performance of its newest drug, Spinraza. Other biotechs like Celgene(CELG - Free Report) and Incyte (INCY - Free Report) too beat on both counts. Also, Alexion’s (ALXN - Free Report) earnings and sales topped the Zacks Consensus Estimate in the first quarter and therefore, the company upped its guidance. Additionally, Vertex’s (VRTX - Free Report) earnings and sales exceeded expectations. Meanwhile, though Amgen (AMGN - Free Report) delivered a positive earnings surprise, its sales came in line with the consensus mark.
Alexion currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Gets FDA Nod for Label Expansion of Kalydeco: Vertex Pharmaceuticals announced the FDA approval of cystic fibrosis (CF) drug Kalydeco’s label expansion. The drug has been approved for use in children suffering cystic fibrosis aged from six to less than 12 months with at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on the clinical and/or in vitro assay data. Kalydeco is already approved in the United States, Canada and EU for the treatment of CF in patients aged 12 months and above. The regulatory agency’s approval was based on data from a 24-week phase III open-label safety cohort (ARRIVAL) of 11 children with CF, aged from six to less than 12 months.
Alexion’s Ultomiris Receives Positive CHMP Opinion: Alexion announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending marketing authorization for the long-acting C5 complement inhibitor, Ultomiris (ravulizumab). The committee has recommended the drug’s approval for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) with haemolysis involving clinical symptoms, indicative of a high disease activity. The drug has also been recommended for adult patients, who are clinically stable after being treated with Soliris for at least the past six months.
The European Commission will review the CHMP recommendation and a final decision is expected in two months. The FDA approved Ultomiris for adult patients with PNH last December.
Celgene, Acceleron Pharma Submit Luspatercept Application in Europe: Celgene announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for luspatercept. The company along with partner Acceleron Pharma is seeking an approval of the drug for treating adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia, who have ring sideroblasts, require red blood cell (RBC) transfusions and have received or are not eligible for erythropoiesis-stimulating agents. The same is also sought for the treatment of adult subjects with beta-thalassemia-associated anemia, requiring RBC transfusions.
Regeneron Wins FDA Nod for Label Expansion of Praluent: Regeneron (REGN - Free Report) along with partner Sanofi announced that the FDA has approved a label expansion of its PCSK9 inhibitor, Praluent (alirocumab). The drug is now approved to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization of the adults suffering from established cardiovascular (CV) disease. The FDA approval is based on the findings from ODYSSEY OUTCOMES. The FDA also approved Praluent as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to lessen LDL-C.
Concurrently, both companies announced that European Medicines Agency's (EMA) CHMP has adopted a positive opinion for the marketing authorization of Libtayo (cemiplimab). The CHMP recommended its conditional approval for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), who are not candidates for curative surgery or curative radiation.
Incyte Opts Out of Baricitinib Development Program: Incyte announced that it will no longer co-fund the development of baricitinib in order to reallocate capital for other promising internal projects. However, the company will continue to receive royalties on global net sales of Olumiant, pursuant to the terms of its agreement with Lilly. Lilly plans to share data from BREEZE-AD1 and BREEZE-AD2, the two phase III studies of baricitinib on patients with moderate-to-severe atopic dermatitis later this year, and also expects to provide top-line results from the other ongoing phase III programs for this indication later in 2019.
The NASDAQ Biotechnology index dipped 0.48% in the past five trading sessions. Among the major biotech giants, Gilead gained 3.17% in the period. Over the past six months, shares of Celgene have surged 30.85% whereas the Biogen stock has lost 25.2% of value. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD Collaborates on NASH, FCSC Surges on Deal)
What's Next in Biotech?
Stay tuned for more earnings updates along with regular pipeline developments.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 7 stocks to watch. The report is only available for a limited time.
See 7 breakthrough stocks now>>